Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL (REF 021.5510)Recalls & reported problems
Institut Straumann AG · Bone Level Tapered Implant, D 4.1mm RC, SLA® 10mm, Roxolid®, Loxim™ · Class 2 · Implant
All models of Straumann Dental Implant System Roxolid SLA Impl. (80)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Straumann SLA Roxolid dental implant, a tapered implant. Its reports mostly describe implants that failed to fuse with the bone, with some mentioning pain, infection or tissue damage. There are 43,316 reports, with no deaths and 43,316 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 43,616
- Deaths reported
- 0
- Injuries reported
- 43,616
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43,616 adverse event reports that list this exact device (DI 07630031707130), received between Apr 30, 2018 and Sep 30, 2026 — classified as 43,616 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (32,173 reports).
2 other recalls cover devices cleared under the same FDA submission (K150938); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate32,173
- Loss of Osseointegration9,442
- Adverse Event Without Identified Device or Use Problem1,653
- Difficult to Insert226
- Fracture185
- Separation Failure61
- Unintended Movement22
- Unstable21
Patient problems
- No Clinical Signs, Symptoms or Conditions17,072
- Fibrosis14,578
- Pain9,882
- Unspecified Infection7,956
- Inflammation3,459
- Tissue Damage3,352
- Swelling/ Edema2,620
- Hemorrhage/Blood Loss/Bleeding2,565
Recent adverse event reports
The 25 most recent of 43,616 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950320 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922038 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Numbness
MAUDE report 50921971 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921857 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921852 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50921843 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50921521 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Hyperresponsive to stimuli; Inflammation; Unspecified Infection
MAUDE report 50921508 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Hyperresponsive to stimuli; Unspecified Infection
MAUDE report 50921503 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921457 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921235 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Pain
MAUDE report 50921229 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921223 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Hyperresponsive to stimuli; Hypersensitivity/Allergic reaction; Pain
MAUDE report 50921161 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Hyperresponsive to stimuli; Inflammation; Pain
MAUDE report 50921142 ↗InjurySep 28, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 35. On 2026-05-09, non-osseointegration was verified. The device was forwarded to the manufacturer. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920956 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920866 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920725 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50920712 ↗InjurySep 28, 2026Difficult to Insert
The clinician reports that the day the implant was placed in the patient's mouth, failure occurred upon insertion. Details of surgery: Primary stability not achieved and Implant surface not completely covered with bone. Patient presented with bone type III and inadequate bone quality/quantity. No product was returned to the manufacturer. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920709 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Hypersensitivity/Allergic reaction
MAUDE report 50920698 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Hypersensitivity/Allergic reaction
MAUDE report 50920696 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fistula; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50920691 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50920663 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50920659 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K150938. One submission often covers many models, so check the product and lot details in each record.
- Z-2534-2016 · Jul 14, 2016 · TerminatedStraumann Bone Level Implant, 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510
- Z-2535-2016 · Jul 14, 2016 · TerminatedStraumann Bone Level Implant, 4.1mm RC, SLA 12mm, TiZr, NTP Article Number: 021.4512
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid TLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM21,217 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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